JOB PURPOSE :
As site Quality technical expert, leads the team of Quality Engineers responsible for the review of product and process design for manufacturability and execution of root cause analysis. In alignment with company strategy to positively impact business efficiency and company profitability, increases team focus on identifying solutions, problem solving, and maximizing supply chain collaboration. Plans, coordinates and assigns projects, and defines the scope of work. Supports the team through the removal of technical barriers; develops and executes complex experiments requiring diverse levels of knowledge and experience. Provides leadership to direct Quality’s involvement in product development programs during concept, design & development and testing phases, and to guarantee customer satisfaction through successful product launches. To supportthese programs, trains direct reports on complex Quality and Six Sigma tools such as Define, Measure, Analyze, Improve & Control (DMAIC) improvement cycle, Failure Mode Effects Analysis (FMEA), control charting and problem-solving.
As part of the Quality leadership team, ensures that quality and safety are infused to the culture, the daily activities, and the behaviors of team members. Maintains team awareness of global Quality initiatives and leads collaboration efforts with international Quality partners and the Quality Engineering teams within Mary Kay. Develops global quality policies, procedures and standards and assesses the effectiveness and sustainability of processes. Leads industry benchmarking activities within Quality and Quality Engineering fields of expertise and implements best practices as appropriate.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Supervises the Quality Engineering function responsible for resolving complex product development, package development, process development, manufacturing operations, and quality control problems using analytical data, statistical methods, ingenuity and creativity. Develops staff, prioritizes projects, and reports results to leadership professionally and timely. Maintains appropriate focus on short and long-term goals and develops a healthy work balance between pro-active and reactive tasks. Refines the structure and framework of the QE function.
2. Plans and coordinates activities for the Quality Engineering function, to include assessing risk levels, establishing priorities, and managing budgetary limits. Provides technical direction and supervision to direct reports to help meet established schedules and/or resolve technical or operational problems. Responsible for the on-going coaching, mentoring, training and continued growth & development of team members and prepares and administers performance reviews. Develops and maintains a safe, positive working environment for the department.
3. Serves as technical unit leader to represent Quality in the Design for Manufacturability (DfM) efforts. Duties are aimed at minimizing any negative impact on products such as product failure, product liability, missed product launch dates, and poor product image in the marketplace. Objective is to assure product integrity and minimize any negative impact on products and Company goals and objectives by being pro-active to prevent potential problems through technical reviews of products, formulas, processes and procedures. Leadership of the Quality Engineering team in relation to the DfM initiative will focus on establishing meaningful specifications with critical to quality attributes identified, processes with critical control points identified, standards and test methodology necessary for executing global product programs. Assures Voice of the Customer data is reviewed and converted to information by QE for use by product and process design teams and for immediate resolution where warranted. Oversees development of test methodologies to include industry standard methods and potential implementation of novel or state-of-the-art technologies. Knowledgeable of a wide range of analytical and statistical techniques and methodologies necessary to solve complex problems, and guides/trains team members to employ them.
4. Works cooperatively through the product development process with other groups such as Procurement, Engineering, Operations, Research & Development, Marketing, and Program Management. Maintains an awareness of project plans, development and production timelines, and conducts technical reviews aimed at documenting specified test requirements, methods and standards unique to various products and packages. Assures appropriate personnel are properly educated and trained to conduct process audits for the manufacture of new or current products and to monitor manufacturing process performance. Trains on complex Quality and Six Sigma tools such as DMAIC, FMEA, control charting and problem-solving. Drives timely and effective completion of root cause analysis and CAPA activities.
5. Responsible for researching and solving problems through planning, developing and executing complex experiments requiring diverse levels of knowledge and experience. Exercises considerable latitude in determining technical objectives of assignments. Completes assigned project responsibilities independently or in support of a project team. Communicates team plans, results, and issues promptly to maximize organizational success. Work is performed without appreciable direction. Works effectively against established deadlines.
6. Oversees the handoff of product and process development and Corrective Action Preventive Action (CAPA) information from Quality Engineering to the site Quality functions. Works cooperatively with team members from other departments to ensure successful attainment of objectives and fulfillment of missions. Interacts with management onsignificant technical matters often requiring the coordination of activities across organizational lines.
KNOWLEDGE, SKILLS AND ABILITIES:
Education: Bachelor's degree or higher in a related Engineering or Technical discipline.
Experience: 5+ years of experience as a Quality Engineer in a GMP environment; experience with complex supply chains and large international supplier base are preferred. Active certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Six Sigma Black Belt (CSSBB) is required.
1. Must possess extensive expertise as a specialist with a wide application of principles, theories, and concepts in the areas of quality engineering plus a working knowledge of other related disciplines. Experience with food, drug, and/or cosmetic industry is preferred. An understanding of FDA regulations is recommended.
2. Must be able to develop solutions to complex problems which require the regular use of ingenuity and creativity.
3. Must have strong supervisory skills and be able to lead, focus and inspire a diverse team of technical experts.
4. Must have a proven track record of driving continuous improvement in a manufacturing environment and have a thirst for seeking new knowledge and application opportunities.
5. Must possess excellent written and oral communication skills and the ability to facilitate communications between various groups to achieve quality objectives.
6. Ability to perform duties under very general direction and independently perform assignments with only general criteria for expected results and exercise considerable latitude in determining technical objective of assignments.